IN.PACT™ Admiral™ ADM04008008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169383470), received between Apr 5, 2019 and Aug 15, 2019 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (P140010); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO INPACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE RIGHT MID SFA (R1 AND R2) . APPROX 11 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED ARTERIO SCLEROSIS OBLITERANS. OCCLUSION WAS OBSERVED IN AN ARTERY IN THE TARGET LIMB. THE PATIENT WAS TREATED WITH PTA OF THE TARGET LESION. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, PROCEDURE OR PACLITAXEL. SAFETY ASSESSED THE EVENT AS PROBABLY RELATED TO THE INDEX DEVICE AND PROCEDURE AND POSSIBLY RELATED TO PACLITAXEL.

  Patient problems: Occlusion

  MAUDE report 8896178 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCBS WERE USED TO TREAT THE RIGHT MID SFA (R1 & R2). APPROXIMATELY 4.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED ATHEROSCLEROSIS OBLITERANS OF TARGET LESION, TARGET LIMB ARTERY WAS OCCLUDED. THE PATIENT WAS TREATED WITH PTA AND DCB OF THE TARGET LESION. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury; Occlusion

  MAUDE report 8611791 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE IN.PACT ADMIRAL DCB WERE USED, TWO TO THE TREAT THE LEFT POPLITEAL AND ONE TO TREAT THE RIGHT POPLITEAL. DISSECTION WAS REPORTED DURING THE PROCEDURE BUT NO STENTING WAS CARRIED OUT. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT POPLITEAL ARTERY STENOSIS. CYANOSIS OF LEFT FOOT WAS CONFIRMED BY ANGIO. EVENT WAS TREATED WITH PTA OF TARGET LESION. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE, AND NOT RELATED TO THE PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 8486789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140010. One submission often covers many models, so check the product and lot details in each record.

• Z-1042-2022 · Mar 23, 2022 · Open, Classified
  Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM040120